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Responsible Life Sciences Research for Global Health Security: A Guidance Document. Geneva: World Health Organization; 2010.

Cover of Responsible Life Sciences Research for Global Health Security

Responsible Life Sciences Research for Global Health Security: A Guidance Document.

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4The way forward: the self-assessment questionnaire

This guidance promotes a culture of scientific integrity and excellence, distinguished by openness, honesty, accountability and responsibility. Such a culture is the best protection against accidents, the inadvertent harmful consequences of research and deliberate misuse, and the best guarantee of scientific progress and development.

This guidance has identified three pillars of a biorisk management framework for responsible life sciences research: research excellence, ethics, and biosafety and laboratory biosecurity. The self-assessment questionnaire presented below (Section 4.3) is intended to help health policy-makers, health professionals, laboratory managers, professional associations and individual scientists assess the extent to which elements related to the three pillars are in place – in the national public health system and in individual laboratories – to identify their respective strengths and weaknesses, and to build on their strengths and address their weaknesses in each of these three pillars. It can be used in a number of other ways, as explained below in Section 4.2.

There is no single solution or system that will suit all countries and all laboratories. Each interested country or institution needs to assess the extent to which it has systems and practices in place to deal with this issue at local and national levels, and to decide which measures need to be reinforced.

In general, oversight, safety and public security should be pursued in a manner that maximizes scientific progress and preserves scientific freedom. This requires excellent facilities, and the management of them (including laboratories), leadership with integrity, a robust ethical framework, training and capacities development, institutional development and regular review.

4.1. Using the self-assessment tool

Self-assessment is a process that begins with an identification of strengths, weaknesses and gaps and concludes with action to address the gaps and weaknesses and to build on or consolidate the strengths.

The questionnaire that follows allows users to assess the extent to which structures, mechanisms and processes are in place that will facilitate and ensure excellence in science, safety and security. The second part of the process of self-assessment requires users to consider those areas that have been identified as weaknesses or gaps through answering the questions. This second stage may involve meetings with others who are involved in laboratory management or policy formulation. The final aspect of self-assessment is corrective action to address gaps or weaknesses identified.

The questionnaire can be used as a quick assessment for individuals in senior government positions, or even laboratory managers. It can also be completed by employees at a research facility as a process of assessing the institution.

Aside from its primary purpose of assessment, the questionnaire is also intended to stimulate discussion and debate about the issues raised, to raise awareness about the three pillars of the biorisk management framework, and to provide a basis for thinking about what is necessary to ensure good quality, responsible activities in the life sciences.

4.2. Interpreting the results of the self-assessment tool

If the questionnaire is to be used as a quick assessment for individuals in senior government positions, or laboratory managers the user may find that the first time they try to answer the questions, many of the answers will be “don’t know”. In other words, it is likely that many respondents, particularly senior government officials, may not have an overview of the detailed implementation of systems for safety, security and ethics at public health facilities. An answer of “don’t know” on any of the questions should indicate to the user that they need to find out more information about that particular issue.

So, answering the questionnaire quickly, before consulting laboratory managers or public health care facility managers will enable the user to identify those areas where she or he requires more information. After consultations to gather information the user may wish to fill in the questionnaire once again. This time there may be fewer “don’t know” responses and more that fall into the categories “agree” or “disagree”. Where the answers are “disagree” the user should be alerted to the fact that action may need to be taken to address the situation. For example, if the answer to the question “Facilities and equipment are appropriate to the level of work being done and are adequately maintained” is “disagree” or “strongly disagree” it is clear that the facilities and equipment are not appropriate to the level of work being done, or are not adequately maintained. This may present a safety risk, both to the public and to those working in the laboratory and suggests that measures need to be taken to address the problem. On the other hand, a response of “agree” or “strongly agree” shows that appropriate measures are already in place.

If the questionnaire is completed by a group of laboratory scientists the results may be interpreted slightly differently. In this case a large number of “don’t know” answers to any one of the questions may indicate that staff is uninformed about the particular issues being probed. For example “don’t know” responses to the question “Research priorities are in line with national health needs” suggests that laboratory staff do not know what the national health needs are, or may suggest that when research projects are initiated consideration is not given to whether the research is in line with national health needs. Whichever of the two it is, the answer “don’t know” should indicate to managerial staff that there is a need to discuss the issue further with their staff.

In general, for all users of the questionnaire, answers of “agree” or “strongly agree” to the questions identify strengths; answers of “disagree” or “strongly disagree” indicate weaknesses and answers of “don’t know” indicate gaps in knowledge (in other words issues for which more information may be required).

4.3. The self-assessment questionnaire

Self-assessment: Responsible life sciences research

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Bookshelf ID: NBK305041

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